# K251165: Saans (F4-01-00-000-000)

- Pathway: 510(k) (Traditional)
- Applicant: Innaccel Technologies Private Limited
- Decided: Jan 6, 2026 after 266 days
- Product code: SGR (Noninvasive Positive Airway Pressure System, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K093633 (2010). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222644: Nihon Kohden NKV-440 Ventilator System, Nihon Kohden Orangemed, Inc. (2023) Summary page 5.

## Indications for use
The Saans System is intended to provide continuous positive airway pressure (CPAP) support to spontaneously breathing neonates and infants weighing up to 10 kg who require respiratory assistance, including those with conditions associated with prematurity such as Respiratory Distress Syndrome (RDS). The device is intended for use in hospital environments.

Source page: https://510kreport.com/device/K251165
Methodology: https://510kreport.com/methodology